APLICARE HYDROGEN PEROXIDE- hydrogen peroxide liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)

Available from:

Aplicare Products, LLC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

First Aid Antiseptic - topical anti-infective

Authorization status:

OTC monograph not final

Summary of Product characteristics

APLICARE HYDROGEN PEROXIDE- HYDROGEN PEROXIDE LIQUID
APLICARE PRODUCTS, LLC
----------
0013 APLICARE HYDROGEN PEROXIDE
_ACTIVE INGREDIENT_
Hydrogen peroxide USP 3%
_PURPOSE_
First Aid Antiseptic
_USE_
topical anti-infective
_WARNINGS_
FOR EXTERNAL USE ONLY.
AVOID POOLING BENEATH PATIENT
ASK A DOCTOR BEFORE USE IF INJURIES ARE
• deep or puncture wounds
• serious burns
STOP USE AND ASK A DOCTOR IF
• infection occurs
• redness, irritation, swelling or pain persists or increases
KEEP OUT OF REACH OF CHILDREN.
In case of accidental ingestion, seek professional assistance or
consult a poison control
center immediately.
_DIRECTIONS_
• apply locally as needed
_OTHER INFORMATION_
• not made with natural rubber latex
• protect from freezing, avoid excessive heat
_INACTIVE INGREDIENTS_
water
MANUFACTURING INFORMATION
Manufactured by:
Aplicare Products, LLC.
550 Research Parkway, Meriden, CT 06450 USA
1-800-633-5463
0110
PACKAGE LABEL
APLICARE HYDROGEN PEROXIDE
hydrogen peroxide liquid
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:52380-0013
ROUTE OF ADMINISTRATION
TOPICAL
Aplicare Products, LLC
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE -
UNII:BBX060AN9V)
HYDROGEN
PEROXIDE
3 mL
in 100 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
WATER (UNII: 059QF0KO0R)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:52380-
0013-1
30 mL in 1 PACKET; Type 0: Not a Combination
Product
12/01/1983
06/30/2026
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
OTC Monograph Drug
M003
12/01/1983
06/30/2026
LABELER -
Aplicare Products, LLC (081054904)
REGISTRANT -
Medline Industries, LP (025460908)
Revised: 10/2023